The near immediate use of the drugs means that the environment in which they are produced has to be constantly monitored and controlled. “So you have to know about any problem with the production environment immediately, in real time.”
This means that pharmacy clean rooms are designed with a continuous particle monitoring system. It alerts staff immediately should any contamination occur.
WSP was recently commissioned to design and oversee construction and commissioning of mechanical, electrical, fire and hydraulic services including central energy plants, heat recovery units and supply and return HEPA filtration at several compounding sites. The facilities comprise cytotoxic and aseptic containment dispensaries and ancillary clean rooms, preparation rooms, packaging areas and offices. The facilities are certified by Australia’s Therapeutic Goods Administration (TGA).
Cytotoxic drugs are made up in secure cytotoxic cabinets – “a little like hi-tech fume cupboards”, says Pleaner. To ensure the safety of staff, as well as to maintain the highest levels of air purity, the clean room air supply is direct path with no recirculation, he adds. “Of course, this is energy-intensive from a heating and cooling point of view, so we have designed a 75% efficient heat recovery system for the air handling plant which will substantially decrease energy use and costs for our client.”